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4. Breast Cancer

Author

Rottmann, Nina, Ewertz, Marianne, Hansen, Dorte Gilså, Tognetti, Mara, Section editor, and Maggino, Filomena, editor

Published
2023
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6. Anthracycline-containing and taxane-containing chemotherapy for early-stage operable breast cancer: a patient-level meta-analysis of 100 000 women from 86 randomised trials

Author

Braybrooke, Jeremy, Bradley, Rosie, Gray, Richard, Hills, Robert K, Pan, Hongchao, Peto, Richard, Dodwell, David, McGale, Paul, Taylor, Carolyn, Aihara, Tomohiko, Anderson, Stewart, Blum, Joanne, Cardoso, Fatima, Chen, Xiaosong, Crown, John P, Ejlertsen, Bent, Friedl, Thomas W P, Harbeck, Nadia, Janni, Wolfgang, Jensen, Maj-Britt, Mamounas, Eleftherios, Narui, Kazutaka, Nitz, Ulrike, Norton, Larry, O'Shaughnessy, Joyce, Piccart, Martine, Robert, Nicholas, Shao, Zhi-Ming, Slamon, Dennis, Sparano, Joseph, Watanabe, Toru, Yothers, Greg, Yu, Ke-Da, Berry, Richard, Boddington, Clare, Clarke, Mike, Davies, Christina, Davies, Lucy, Duane, Fran, Evans, Vaughan, Gay, Jo, Gettins, Lucy, Godwin, Jon, James, Sam, Lui, Hui, Lui, Zulian, MacKinnon, Elizabeth, Mannu, Gurdeep, McHugh, Theresa, Morris, Philip, Read, Simon, Straiton, Ewan, Buzdar, Aman, Suman, Vera J, Hunt, Kelly K, Leonard, Robert C F, Mansi, Janine, Delbaldo, Catherine, Piedbois, Pascal, Quinaux, Emmanuel, Fesl, Christian, Gnant, Michael, Sölkner, Lidija, Steger, Guenther, Eikesdal, Hans Petter, Lønning, Per Eystein, Bee, Valerie, Fung, Helena, Mackey, John, Martin, Miguel, Press, Michael, De Azambuja, Evandro, Gelber, Richard, Regan, Meredith, Di Leo, Angelo, Van Dooren, Veerle, Nogaret, Jean Marie, Bartlett, John, Chen, Bingshu E, Gelmon, Karen, Goss, Paul E, Levine, Mark N, Parulekar, Wendy, Pritchard, Kathleen I, Shepherd, Lois, Berry, Donald, Cirrincione, Constance, Shulman, Lawrence N, Winer, Eric, Gelman, Rebecca S, Harris, Jay R, Henderson, Craig, Shapiro, Charles L, Christiansen, Peer, Ewertz, Marianne, Mouridsen, Henning T, Van Leeuwen, Elise, Linn, Sabine, Van Rossum, Annelot G J, Van Tinteren, Harm, Van Werkhoven, Erik, Goldstein, Lori, Gray, Robert, Eiermann, Wolfgang, Gianni, Luca, Valagussa, Pinuccia, Bogaerts, Jan, Bonnefoi, Herve, Poncet, Coralie, Huovinen, Riikka, Joensuu, Heikki, Bonneterre, Jacques, Fargeot, Pierre, Fumoleau, Pierre, Kerbrat, Pierre, Luporsi, Elisabeth, Namer, Moïse, Carrasco, Eva M, Segui, Miguel Angel, Meisner, Christoph, Loibl, Sibylle, Nekljudova, Valentina, Thomssen, Christoph, Von Minckwitz, Gunter, Kümmel, Sherko, Lopez, Massimo, Vici, Patrizia, Fountzilas, George, Koliou, Georgia, Mavroudis, Dimitrios, Saloustros, Emmanouil, Brain, Etienne, Delaloge, Suzette, Michiels, Stefan, Mathoulin-Pelissier, Simone, Bines, Jose, Sarmento, Roberta M B, Bonadonna, Gianni, Brambilla, Cristina, Rossi, Anna, Bliss, Judith, Coombes, Raoul Charles, Kilburn, Lucy, Marty, Michel, Amadori, Dino, Boccardo, Francesco, Nanni, Oriana, Rubagotti, Alessandra, Scarpi, Emanuela, Masuda, Norikazu, Toi, Masakazu, Ueno, Takayuki, Ishikawa, Takashi, Matsumoto, Koji, Takao, Shintaro, Sommer, Harald, Foroglou, Pericles, Giokas, George, Kondylis, D, Lissaios, Byron, Reinisch, Mattea, Lee, Keun Seok, Nam, Byung-Ho, Ro, Jung Sil, De Matteis, Andrea, Perrone, Francesco, Tang, Gong, Wolmark, Norman, Hozumi, Yasuo, Nomura, Yasuo, Earl, Helena, Hiller, Louise, Vallier, Anne-Laure, De Mastro, Lucia, Venturini, Macro, Delozier, Thierry, Lemonnier, Jerome, Martin, Anne-Laure, Roché, Henri, Spielmann, Marc, Chen, Xiasong, Shen, Kunwei, Albain, Kathy, Barlow, William, Budd, George T, Gralow, Julie, Hayes, Dan, Bartlett-Lee, Peter, Ellis, Paul, Bianco, Angelo Raffaele, De Laurentiis, Michelino, De Placido, Sabino, Wildiers, Hans, Hsu, Limin, Eremin, Oleg, Walker, Leslie G, Ahlgren, Johan, Blomqvist, Carl, Holmberg, Lars, Lindman, Henrik, Asmar, Lina, Jones, Stephen E, Gluz, Oleg, Liedtke, Cornelia, Arriagada, Rodrigo, Bergsten-Nordström, Elizabeth, Carey, Lisa, Coleman, Robert, Cuzick, Jack, Davidson, Nancy, Dignam, James, Dowsett, Mitch, Francis, Prudence A, Goetz, Matthew P, Goodwin, Pam, Halpin-Murphy, Pat, Hill, Catherine, Jagsi, Reshma, Mukai, Hirofumi, Ohashi, Yasuo, Pierce, Lori, Poortmans, Philip, Raina, Vinod, Rea, Daniel, Robertson, John, Rutgers, Emiel, Salgado, Roberto, Spanic, Tanja, Tutt, Andrew, Viale, Giuseppe, Wang, Xiang, Whelan, Tim, Wilcken, Nicholas, Cameron, David, Bergh, Jonas, and Swain, Sandra M

Published
2023
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11. A phase II study of combined ridaforolimus and dalotuzumab compared with exemestane in patients with estrogen receptor-positive breast cancer

Author

Baselga, José, Morales, Serafin M, Awada, Ahmad, Blum, Joanne L, Tan, Antoinette R, Ewertz, Marianne, Cortes, Javier, Moy, Beverly, Ruddy, Kathryn J, Haddad, Tufia, Ciruelos, Eva M, Vuylsteke, Peter, Ebbinghaus, Scot, Im, Ellie, Eaton, Lamar, Pathiraja, Kumudu, Gause, Christine, Mauro, David, Jones, Mary Beth, and Rugo, Hope S

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Estrogen, Patient Safety, Clinical Research, Cancer, Breast Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Androstadienes, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Aromatase Inhibitors, Breast Neoplasms, Disease-Free Survival, Female, Humans, Middle Aged, Protein Kinase Inhibitors, Receptors, Estrogen, Sirolimus, Stomatitis, Ridaforolimus, mTOR, Dalotuzumab, IGF1R, Breast cancer, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeCombining the mTOR inhibitor ridaforolimus and the anti-IGFR antibody dalotuzumab demonstrated antitumor activity, including partial responses, in estrogen receptor (ER)-positive advanced breast cancer, especially in high proliferation tumors (Ki67 > 15%).MethodsThis randomized, multicenter, international, phase II study enrolled postmenopausal women with advanced ER-positive breast cancer previously treated with a nonsteroidal aromatase inhibitor (NCT01234857). Patients were randomized to either oral ridaforolimus 30 mg daily for 5 of 7 days (once daily [qd] × 5 days/week) plus intravenous dalotuzumab 10 mg/kg/week or oral exemestane 25 mg/day, and stratified by Ki67 status. Due to a high incidence of stomatitis in the ridaforolimus-dalotuzumab group, two sequential, nonrandomized, reduced-dose cohorts were explored with ridaforolimus 20 and 10 mg qd × 5 days/week. The primary endpoint was progression-free survival (PFS).ResultsMedian PFS was 21.4 weeks for ridaforolimus 30 mg qd × 5 days/week plus dalotuzumab 10 mg/kg (n = 29) and 24.3 weeks for exemestane (n = 33; hazard ratio = 1.00; P = 0.5). Overall survival and objective response rates were similar between treatment arms. The incidence of drug-related, nonserious, and serious adverse events was higher with ridaforolimus/dalotuzumab (any ridaforolimus dose) than with exemestane. Lowering the ridaforolimus dose reduced the incidence of grade 3 stomatitis, but overall toxicity remained higher than acceptable at all doses without improved efficacy.ConclusionsThe combination of ridaforolimus plus dalotuzumab was no more effective than exemestane in patients with advanced ER-positive breast cancer, and the incidence of adverse events was higher. Therefore, the combination is not being further pursued.

Published
2017

12. Effects of comprehensive geriatric assessment-guided interventions on physical performance and quality of life in older patients with advanced cancer:A randomized controlled trial (PROGNOSIS-RCT)

Author

Giger, Ann Kristine W., Ditzel, Helena M., Ditzel, Henrik J., Ewertz, Marianne, Jørgensen, Trine Lembrecht, Pfeiffer, Per, Lund, Cecilia M., Ryg, Jesper, Giger, Ann Kristine W., Ditzel, Helena M., Ditzel, Henrik J., Ewertz, Marianne, Jørgensen, Trine Lembrecht, Pfeiffer, Per, Lund, Cecilia M., and Ryg, Jesper

Abstract

Introduction Older patients with frailty starting oncological treatment are at higher risk of experiencing declining physical performance, loss of independence, and quality of life (QoL). This study examines whether comprehensive geriatric assessment (CGA)-guided interventions added to standard oncological care can prevent declining physical performance and QoL in older patients with frailty initiating palliative treatment. Materials and Methods Patients aged ≥70 years, with a Geriatric-8 score of ≤14, initiating palliative oncological treatment were enrolled in an open label randomized controlled trial and randomized 1:1 to receive either CGA-guided interventions in addition to oncological standard care or oncological care alone. Baseline characteristics, physical performance measures, and QoL questionnaires were retrieved before group allocation. CGA was performed using a fixed set of domains and validated tests by a geriatrician-led team. The primary endpoint, physical performance, was measured by the 30-s chair stand test (30s-CST) at three months. Additional outcomes included 30s-CST at six months, handgrip strength test, and QoL. Outcomes were analyzed using linear mixed regression models. The trial was registered at clinicaltrials.org (NCT04686851). Results From November 1, 2020 to May 31, 2022, 181 patients were included; 88 in the interventional arm and 93 in the control arm. Median age was 77 (interquartile range [IQR] 73–81) years, 69% were male, median Geriatric-8 score was 12 (IQR 10–13), 69% had a Performance Status of 0–1, and the median 30s-CST was 9 (IQR 5–11) repetitions. The between-group difference in 30s-CST at three months was 0.67 (95%CI: −0.94 − 2.29) and 1.57 (95%CI: −0.20 − 3.34) at six months, which were not statistically significant. Subgroup analysis including participants with a baseline Geriatric-8 of 12–14 found borderline significant between-group differences in 30s-CST scores at three and six months of, Introduction: Older patients with frailty starting oncological treatment are at higher risk of experiencing declining physical performance, loss of independence, and quality of life (QoL). This study examines whether comprehensive geriatric assessment (CGA)-guided interventions added to standard oncological care can prevent declining physical performance and QoL in older patients with frailty initiating palliative treatment. Materials and Methods: Patients aged ≥70 years, with a Geriatric-8 score of ≤14, initiating palliative oncological treatment were enrolled in an open label randomized controlled trial and randomized 1:1 to receive either CGA-guided interventions in addition to oncological standard care or oncological care alone. Baseline characteristics, physical performance measures, and QoL questionnaires were retrieved before group allocation. CGA was performed using a fixed set of domains and validated tests by a geriatrician-led team. The primary endpoint, physical performance, was measured by the 30-s chair stand test (30s-CST) at three months. Additional outcomes included 30s-CST at six months, handgrip strength test, and QoL. Outcomes were analyzed using linear mixed regression models. The trial was registered at clinicaltrials.org (NCT04686851). Results: From November 1, 2020 to May 31, 2022, 181 patients were included; 88 in the interventional arm and 93 in the control arm. Median age was 77 (interquartile range [IQR] 73–81) years, 69% were male, median Geriatric-8 score was 12 (IQR 10–13), 69% had a Performance Status of 0–1, and the median 30s-CST was 9 (IQR 5–11) repetitions. The between-group difference in 30s-CST at three months was 0.67 (95%CI: −0.94 − 2.29) and 1.57 (95%CI: −0.20 − 3.34) at six months, which were not statistically significant. Subgroup analysis including participants with a baseline Geriatric-8 of 12–14 found borderline significant between-group differences in 30s-CST scores at three and six months of 2.04 (95% confidence int

Published
2024

21. The Pattern of Metastatic Breast Cancer: A Prospective Head-to-Head Comparison of [18F]FDG-PET/CT and CE-CT

Author

Gram-Nielsen, Rosa, primary, Christensen, Ivar Yannick, additional, Naghavi-Behzad, Mohammad, additional, Dahlsgaard-Wallenius, Sara Elisabeth, additional, Jakobsen, Nick Møldrup, additional, Gerke, Oke, additional, Jensen, Jeanette Dupont, additional, Ewertz, Marianne, additional, Hildebrandt, Malene Grubbe, additional, and Vogsen, Marianne, additional

Published
2023
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24. Ischemic Heart Disease after Breast Cancer Radiotherapy

Author

Darby, Sarah C, Ewertz, Marianne, and Hall, Per

Subjects
Breast Neoplasms, Female, Heart, Humans, Myocardial Ischemia, Radiotherapy, Adjuvant, Medical and Health Sciences, General & Internal Medicine
Published
2013

29. Supplementary Table 2 from Tobacco and Alcohol in Relation to Male Breast Cancer: An Analysis of the Male Breast Cancer Pooling Project Consortium

Author

Cook, Michael B., primary, Guénel, Pascal, primary, Gapstur, Susan M., primary, van den Brandt, Piet A., primary, Michels, Karin B., primary, Casagrande, John T., primary, Cooke, Rosie, primary, Van Den Eeden, Stephen K., primary, Ewertz, Marianne, primary, Falk, Roni T., primary, Gaudet, Mia M., primary, Gkiokas, George, primary, Habel, Laurel A., primary, Hsing, Ann W., primary, Johnson, Kenneth, primary, Kolonel, Laurence N., primary, La Vecchia, Carlo, primary, Lynge, Elsebeth, primary, Lubin, Jay H., primary, McCormack, Valerie A., primary, Negri, Eva, primary, Olsson, Håkan, primary, Parisi, Dominick, primary, Petridou, Eleni Th., primary, Riboli, Elio, primary, Sesso, Howard D., primary, Swerdlow, Anthony, primary, Thomas, David B., primary, Willett, Walter C., primary, and Brinton, Louise A., primary

Published
2023
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30. Supplementary Table 3 from Tobacco and Alcohol in Relation to Male Breast Cancer: An Analysis of the Male Breast Cancer Pooling Project Consortium

Author

Cook, Michael B., primary, Guénel, Pascal, primary, Gapstur, Susan M., primary, van den Brandt, Piet A., primary, Michels, Karin B., primary, Casagrande, John T., primary, Cooke, Rosie, primary, Van Den Eeden, Stephen K., primary, Ewertz, Marianne, primary, Falk, Roni T., primary, Gaudet, Mia M., primary, Gkiokas, George, primary, Habel, Laurel A., primary, Hsing, Ann W., primary, Johnson, Kenneth, primary, Kolonel, Laurence N., primary, La Vecchia, Carlo, primary, Lynge, Elsebeth, primary, Lubin, Jay H., primary, McCormack, Valerie A., primary, Negri, Eva, primary, Olsson, Håkan, primary, Parisi, Dominick, primary, Petridou, Eleni Th., primary, Riboli, Elio, primary, Sesso, Howard D., primary, Swerdlow, Anthony, primary, Thomas, David B., primary, Willett, Walter C., primary, and Brinton, Louise A., primary

Published
2023
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31. Supplementary Table 1 from Tobacco and Alcohol in Relation to Male Breast Cancer: An Analysis of the Male Breast Cancer Pooling Project Consortium

Author

Cook, Michael B., primary, Guénel, Pascal, primary, Gapstur, Susan M., primary, van den Brandt, Piet A., primary, Michels, Karin B., primary, Casagrande, John T., primary, Cooke, Rosie, primary, Van Den Eeden, Stephen K., primary, Ewertz, Marianne, primary, Falk, Roni T., primary, Gaudet, Mia M., primary, Gkiokas, George, primary, Habel, Laurel A., primary, Hsing, Ann W., primary, Johnson, Kenneth, primary, Kolonel, Laurence N., primary, La Vecchia, Carlo, primary, Lynge, Elsebeth, primary, Lubin, Jay H., primary, McCormack, Valerie A., primary, Negri, Eva, primary, Olsson, Håkan, primary, Parisi, Dominick, primary, Petridou, Eleni Th., primary, Riboli, Elio, primary, Sesso, Howard D., primary, Swerdlow, Anthony, primary, Thomas, David B., primary, Willett, Walter C., primary, and Brinton, Louise A., primary

Published
2023
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33. Breast Cancer

Author

Rottmann, Nina, Ewertz, Marianne, Hansen, Dorte Gilså, and Michalos, Alex C., editor

Published
2014
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35. The Pattern of Metastatic Breast Cancer: A Prospective Head-to-Head Comparison of [ 18 F]FDG-PET/CT and CE-CT.

Author

Gram-Nielsen, Rosa, Christensen, Ivar Yannick, Naghavi-Behzad, Mohammad, Dahlsgaard-Wallenius, Sara Elisabeth, Jakobsen, Nick Møldrup, Gerke, Oke, Jensen, Jeanette Dupont, Ewertz, Marianne, Hildebrandt, Malene Grubbe, and Vogsen, Marianne

Subjects
METASTATIC breast cancer, LYMPHATIC metastasis, BREAST cancer, RADIOLOGY, BREAST, LUNG diseases, LUNGS
Abstract

The study aimed to compare the metastatic pattern of breast cancer and the intermodality proportion of agreement between [18F]FDG-PET/CT and CE-CT. Women with metastatic breast cancer (MBC) were enrolled prospectively and underwent a combined [18F]FDG-PET/CT and CE-CT scan to diagnose MBC. Experienced nuclear medicine and radiology physicians evaluated the scans blinded to the opposite scan results. Descriptive statistics were applied, and the intermodality proportion of agreement was used to compare [18F]FDG-PET/CT and CE-CT. In total, 76 women with verified MBC were enrolled in the study. The reported number of site-specific metastases for [18F]FDG-PET/CT vs. CE-CT was 53 (69.7%) vs. 44 (57.9%) for bone lesions, 31 (40.8%) vs. 43 (56.6%) for lung lesions, and 16 (21.1%) vs. 23 (30.3%) for liver lesions, respectively. The proportion of agreement between imaging modalities was 76.3% (95% CI 65.2–85.3) for bone lesions; 82.9% (95% CI 72.5–90.6) for liver lesions; 57.9% (95% CI 46.0–69.1) for lung lesions; and 59.2% (95% CI 47.3–70.4) for lymph nodes. In conclusion, bone and distant lymph node metastases were reported more often by [18F]FDG-PET/CT than CE-CT, while liver and lung metastases were reported more often by CE-CT than [18F]FDG-PET/CT. Agreement between scans was highest for bone and liver lesions and lowest for lymph node metastases. [ABSTRACT FROM AUTHOR]

Published
2023
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36. Response Monitoring in Metastatic Breast Cancer: A Prospective Study Comparing18F-FDG PET/CT with Conventional CT

Author

Vogsen, Marianne, primary, Harbo, Frederik, additional, Jakobsen, Nick M., additional, Nissen, Henriette J., additional, Dahlsgaard-Wallenius, Sara E., additional, Gerke, Oke, additional, Jensen, Jeanette D., additional, Asmussen, Jon T., additional, Jylling, Anne Marie B., additional, Braad, Poul-Erik, additional, Vach, Werner, additional, Ewertz, Marianne, additional, and Hildebrandt, Malene G., additional

Published
2022
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37. DPYD genotyping and dihydropyrimidine dehydrogenase (DPD) phenotyping in clinical oncology. A clinically focused minireview

Author

Paulsen, Niels Herluf, primary, Vojdeman, Fie, additional, Andersen, Stig Ejdrup, additional, Bergmann, Troels K., additional, Ewertz, Marianne, additional, Plomgaard, Peter, additional, Hansen, Morten Rix, additional, Esbech, Peter Skov, additional, Pfeiffer, Per, additional, Qvortrup, Camilla, additional, and Damkier, Per, additional

Published
2022
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43. DPYD genotyping and dihydropyrimidine dehydrogenase (DPD) phenotyping in clinical oncology. A clinically focused minireview

Author

Paulsen, Niels Herluf, Vojdeman, Fie, Andersen, Stig Ejdrup, Bergmann, Troels K., Ewertz, Marianne, Plomgaard, Peter, Hansen, Morten Rix, Esbech, Peter Skov, Pfeiffer, Per, Qvortrup, Camilla, Damkier, Per, Paulsen, Niels Herluf, Vojdeman, Fie, Andersen, Stig Ejdrup, Bergmann, Troels K., Ewertz, Marianne, Plomgaard, Peter, Hansen, Morten Rix, Esbech, Peter Skov, Pfeiffer, Per, Qvortrup, Camilla, and Damkier, Per

Abstract

Background: In clinical oncology, systemic 5-fluorouracil (5-FU) and its oral pro-drugs are used to treat a broad group of solid tumours. Patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency are at elevated risk of toxicity if treated with standard doses of 5-FU. DPYD genotyping and measurements of plasma uracil concentration (DPD phenotyping) can be applied as tests for DPD deficiency. In April 2020, the European Medicines Agency recommended pre-treatment DPD testing to reduce the risk of 5-FU-related toxicity. Objectives: The objective of this study is to present the current evidence for DPD testing in routine oncological practice. Methods: Two systematic literature searches were performed following the PRISMA guidelines. We identified studies examining the possible benefit of DPYD genotyping or DPD phenotyping on the toxicity risk. Findings: Nine and 12 studies met the criteria for using DPYD genotyping and DPD phenotyping, respectively. Conclusions: The evidence supporting either DPYD genotyping or DPD phenotyping as pre-treatment tests to reduce 5-FU toxicity is poor. Further evidence is still needed to fully understand and guide clinicians to dose by DPD activity.

Published
2022

44. Predictive value of geriatric oncology screening and geriatric assessment of older patients with cancer:A randomized clinical trial protocol (PROGNOSIS-RCT)

Author

Giger, Ann Kristine Weber, Ditzel, Helena Møgelbjerg, Jørgensen, Trine Lembrecht, Ditzel, Henrik Jørn, Mohammadnejad, Afsaneh, Ewertz, Marianne, Pfeiffer, Per, Lund, Cecilia Margareta, Ryg, Jesper, Giger, Ann Kristine Weber, Ditzel, Helena Møgelbjerg, Jørgensen, Trine Lembrecht, Ditzel, Henrik Jørn, Mohammadnejad, Afsaneh, Ewertz, Marianne, Pfeiffer, Per, Lund, Cecilia Margareta, and Ryg, Jesper

Abstract

Introduction: Comprehensive geriatric assessment (CGA) has been shown to reduce frailty in older patients in general. In older patients with cancer, frailty affects quality of life (QoL), physical function, and survival. However, few studies have examined the effect of CGA as an additional intervention to antineoplastic treatment. This protocol presents a randomized controlled trial, which aims to evaluate the effects of CGA-based interventions in older patients with cancer and Geriatric 8 (G8) identified frailty. Materials and Methods: This randomized controlled trial will include patients, age 70+ years, with solid malignancies and G8 frailty (G8 ≤ 14). Patients will be separated into two groups, with different primary endpoints, depending on palliative or curative antineoplastic treatment initiation, and subsequently randomized 1:1 to either CGA with corresponding interventions or standard of care, along with standardized antineoplastic treatment. A geriatrician led CGA with corresponding interventions and clinical follow-up will be conducted within one month of antineoplastic treatment initiation. The interdisciplinary CGA will cover multiple geriatric domains and employ a standard set of validated assessment tools. Primary endpoints will be physical decline measured with the 30-s Chair-Stand-Test at three months (palliative setting) and unplanned hospital admissions at six months (curative setting). Additional outcomes include QoL, treatment toxicity and adherence, occurrence of polypharmacy, potential drug interactions, potential inappropriate medications, and survival. The primary outcomes will be analyzed using a mixed model regression analysis (30-s chair stand test) and linear regression models (unplanned hospitalizations), with an intention to treat approach. Power calculations reveal the need to enroll 134 (palliative) and 188 (curative) patients. Discussion: The present study will examine whether CGA, as an additional intervention to antineoplastic t

Published
2022

45. 2-[18F]FDG-PET/CT is a better predictor of survival than conventional CT: a prospective study of response monitoring in metastatic breast cancer.

Author

Vogsen, Marianne, Naghavi-Behzad, Mohammad, Harbo, Frederik Graae, Jakobsen, Nick Møldrup, Gerke, Oke, Asmussen, Jon Thor, Nissen, Henriette Juel, Dahlsgaard-Wallenius, Sara Elisabeth, Braad, Poul-Erik, Jensen, Jeanette Dupont, Ewertz, Marianne, and Hildebrandt, Malene Grubbe

Subjects
METASTATIC breast cancer, PROGRESSION-free survival, LONGITUDINAL method, DISEASE progression, MAMMOGRAMS
Abstract

This study aimed to compare CE-CT and 2-[18F]FDG-PET/CT for response monitoring metastatic breast cancer (MBC). The primary objective was to predict progression-free and disease-specific survival for responders vs. non-responders on CE-CT and 2-[18F]FDG-PET/CT. The secondary objective was to assess agreement between response categorization for the two modalities. Treatment response in women with MBC was monitored prospectively by simultaneous CE-CT and 2-[18F]FDG-PET/CT, allowing participants to serve as their own controls. The standardized response evaluation criteria in solid tumors (RECIST 1.1) and PET response criteria in solid tumors (PERCIST) were used for response categorization. For prediction of progression-free and disease-specific survival, treatment response was dichotomized into responders (partial and complete response) and non-responders (stable and progressive disease) at the first follow-up scan. Progression-free survival was defined as the time from baseline until disease progression or death from any cause. Disease-specific survival was defined as the time from baseline until breast cancer-specific death. Agreement between response categorization for both modalities was analyzed for all response categories and responders vs. non-responders. At the first follow-up, tumor response was reported more often by 2-[18F]FDG-PET/CT than CE-CT, with only fair agreement on response categorization between the two modalities (weighted Kappa 0.28). Two-year progression-free survival for responders vs. non-responders by CE-CT was 54.2% vs. 46.0%, compared with 59.1% vs. 14.3% by 2-[18F]FDG-PET/CT. Correspondingly, 2-year disease-specific survival were 83.3% vs. 77.8% for CE-CT and 84.6% vs. 61.9% for 2-[18F]FDG-PET/CT. Tumor response on 2-[18F]FDG-PET/CT was significantly associated with progression-free (HR: 3.49, P < 0.001) and disease-specific survival (HR 2.35, P = 0.008), while no association was found for tumor response on CE-CT. In conclusion, 2-[18F]FDG-PET/CT appears a better predictor of progression-free and disease-specific survival than CE-CT when used to monitor metastatic breast cancer. In addition, we found low concordance between response categorization between the two modalities. Trial registration: Clinical.Trials.gov. NCT03358589. Registered 30/11/2017-Retrospectively registered, http://www.ClinicalTrials.gov. [ABSTRACT FROM AUTHOR]

Published
2023
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